NL-OMON52867招募中3 期
A multicenter, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy and safety of finerenone on morbidity and mortality in participants with heart failure (NYHA II-IV) and left ventricular ejection fraction >= 40% (LVEF >= 40%). - FINEARTS-HF
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- Bayer
- 入组人数
- 73
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Participant (male or female) must be aged 40 years and older, at the time
- •of signing the informed consent.
- •2. Diagnosis of heart failure with NYHA class II-IV, ambulatory or hospitalized
- •primarily for heart failure.
- •3. On diuretic treatment for at least 30 days prior to randomization.
- •4. Documented LVEF of >=40% measured by any modality within the last 12 months.
- •5. Structural heart abnormalities based on any local imaging measurement within
- •the last 12 months, defined by at least one of the following findings: LAD
- •>=3.8cm, LAA >=20cm2, LAVI >30 mL/m2, LVMI >=115 g/m2 (*)/ 95 g/m2 (*), septal
- •thickness or posterior wall thickness >=1.1 cm.
- •6. NT-proBNP >=300 pg/mL (BNP >= 100 pg/mL) in SR and patient does not have an
- •ongoing diagnosis of paroxysmal atrial fibrillation or NT-proBNP >=900 pg/mL
- •(BNP >= 300 pg/mL) in AF or if patient has an ongoing diagnosis of paroxysmal
- •atrial fibrillation obtained at the following time:
- •- Within 90 days prior to randomization if patient had been hospitalized for HF
- •requiring initiation or change in HF therapy or if patient had an urgent visit
- •for HF requiring intravenous (IV) diuretic therapy, both within 90 days prior
- •to randomization
- •- Within 30 days prior to randomization if patient has not been hospitalized
- •for HF nor had an urgent HF visit within the past 90 days.
- •7. Women of childbearing potential can only be included in the study if a
- •pregnancy test is negative at screening and baseline and if they agree to use
- •adequate contraception which is consistent with local regulations regarding the
- •methods for contraception for those participating in clinical trials.
排除标准
- •1. eGFR < 25 mL/min/1.73 m² at either screening or randomization visit.
- •2. Serum/plasma potassium >5.0 mmol/L at either screening or randomization
- •3. Acute inflammatory heart disease, e.g. acute myocarditis, within 90 days
- •prior to randomization
- •4. Myocardial infarction or any event which could have reduced the ejection
- •fraction within 90 days prior to randomization
- •5. Coronary artery bypass graft surgery in the 90 days prior to randomization
- •6. Percutaneous coronary intervention in the 30 days prior to randomization
- •7. Stroke or transient ischemic cerebral attack within 90 days prior to
- •randomization
- •8. Probable alternative cause of participants* HF symptoms that in the opinion
- •of the investigator primarily accounts for patient*s dyspnea such as
- •significant pulmonary disease, anemia or obesity. Specifically, patients with
- •the below are excluded:
- •- Severe pulmonary disease requiring home oxygen, or chronic oral steroid
- •- History of primary pulmonary arterial hypertension
- •- Hemoglobin < 10 g/dl*
- •- Valvular heart disease considered by the investigator to be clinically
- •significant
- •- BMI > 50 kg/m2 at screening
- •9. SBP >=160 mmHg if not on treatment with >=3 blood pressure lowering
- •medications or >=180 mmHg irrespective of treatments, on 2 consecutive
- •measurements at least 2-minute apart, at screening or at randomization
研究者
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